BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK 8

    MDR report key: 3182413 · Received June 21, 2013

    Report

    Report Number
    2024168-2013-03858
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    April 27, 2013
    Report Date
    May 27, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EXCESSIVE FORCE. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE SIMILAR INCIDENTS COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A FEMORAL ARTERY ACCESS APPROACH DURING A PROCEDURE OF THE HEAVILY TORTUOUS, HEAVILY CALCIFIED, DE NOVO DISTAL LEFT ANTERIOR DESCENDING (LAD) THE 2.75 X 33 MULTI-LINK 8 (ML8) STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT COULD NOT CROSS THE LESION. IT WAS NOTED THAT THE DEVICE WAS PUSHED SEVERAL TIMES IN AN ATTEMPT TO CROSS THE LESION AND THE PROXIMAL SHAFT BECAME SEPARATED. THE DEVICE WAS REMOVED AND DISCARDED. A DIFFERENT 2.75 X 33 MM ML8 SDS WAS USED SUCCESSFULLY IN THE PROCEDURE WITHOUT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282066 MULTI-LINK 8 CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 005124Q

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR